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临床试验/NCT07265115
NCT07265115
已完成
不适用

Advanced Preventive Nutritional Supplements Targeting Pathologies in the Preclinical Phase

Centro de Edafología y Biología Aplicada del Segura2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2026年1月12日最近更新:

概览

阶段
不适用
状态
已完成
发起方
Centro de Edafología y Biología Aplicada del Segura
入组人数
21
试验地点
2
主要终点
Incremental Area Under the Curve (iAUC) of blood glucose over 120 minutes

概览

简要总结

The main objective of this intervention study was to evaluate the functionality of a multi-target preparation (rich in phloretin from apple, chromium picolinate, zinc, magnesium and cinnamon extract) on the glucose response of individuals who show factors associated with prediabetes.

详细描述

An interventional study was conducted in collaboration with the Catholic University of San Antonio Murcia (UCAM). A total of 21 prediabetic volunteers (fasting blood glucose levels between 100 and 120 mg/dL) who were not taking diabetes medication or antibiotics during the study were recruited. Pregnant or lactating women were also excluded.

The participants were invited to an information session to learn more about the study objectives and procedures, and they signed informed consent forms. During this first visit, anthropometric measurements were taken, and a questionnaire was administered to gather information about their diet and physical activity. Each volunteer made four more visits to the UCAM facilities. On each visit, the volunteers ingested either a placebo capsule or the formulated dietary supplement, followed by a standard breakfast consisting of three toasted bread slices and two single-serving packets of strawberry or peach jam (resulting in a total carbohydrate intake of 49.5 g). The volunteers were randomly assigned to receive the placebo or the supplemet and each of them was taken twice. At time 0 and at different times after breakfast intake (15, 30, 45, 60, 75, 90, 105 and 120 min) blood glucose was measured using capillary blood sample obtained by finger prick and a glucometer.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Fasting blood glucose values between 100 and 120 mg/dL
  • To be habitual breakfast consumers

排除标准

  • To have diabetes medication during the study
  • To have antibiotics during the study
  • To be pregnant or in lactating period

研究组 & 干预措施

Placebo capsule

Placebo Comparator

Participants receive a matching placebo during their assigned period.

干预措施: Placebo (Dietary Supplement)

Active Capsules

Experimental

Participants receive the supplement during their assigned period.

干预措施: Capsules with active ingredients (Dietary Supplement)

Placebo capsule (repetition)

Placebo Comparator

This arm was a repetition of the placebo intake

干预措施: Placebo Repetition (Dietary Supplement)

Active capsules (repetition)

Experimental

This arm was a repetition of the supplement intake

干预措施: Capsules with active ingredients Repetition (Dietary Supplement)

结局指标

主要结局

Incremental Area Under the Curve (iAUC) of blood glucose over 120 minutes

时间窗: 0 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes and 120 minutes following the consumption of breakfast with each capsule

Capillary blood glucose was monitored using a glucometer

次要结局

  • Total area under the curve (AUC)(0 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes and 120 minutes following the consumption of the breakfast with each capsule)
  • Peak Blood Glucose Concentration(0 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes and 120 minutes following the consumption of the breakfast with each capsule)
  • Blood Glucose Concentration at different times(0 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes and 120 minutes following the consumption of the breakfast with each capsule)
  • Time to peak concentration for glucose(0 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes and 120 minutes following the consumption the breakfast with each capsule.)

研究者

发起方
Centro de Edafología y Biología Aplicada del Segura
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

María-Teresa García-Conesa

Senior Scientist

Centro de Edafología y Biología Aplicada del Segura

研究点 (2)

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